NCT02122094

Brief Summary

This study seeks to implement a sexual health promotion intervention for male sex workers in Hanoi and Ho Chi Minh City, Vietnam. The study hypothesis is that this intervention will increase testing, treatment and vaccination for sexually transmitted infections, including intentions of participants to engage in these services beyond the conclusion of the intervention. At the community level, the study hypothesis is that male sex workers will be more aware of sexual health care and more likely to access these services in the future.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,166

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started May 2013

Typical duration for not_applicable hiv

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 28, 2016

Status Verified

October 1, 2015

Enrollment Period

3.3 years

First QC Date

April 17, 2014

Last Update Submit

September 26, 2016

Conditions

Outcome Measures

Primary Outcomes (3)

  • Acceptance of testing

    Participants in the clinic-based Sexual Health Promotion intervention will accept offer of testing for chlamydia, gonorrhea, syphilis, HIV, HBV and Hepatitis C Virus.

    2 hours

  • Return for test results

    Participants in the clinic-based Sexual Health Promotion intervention will return for their test results

    two weeks

  • Intention to access health services

    Participants who receive the community-based Sexual Health Promotion intervention will report intent to access health services for Sexually Transmitted Infection testing, treatment and vaccination

    two years

Study Arms (1)

Sexual Health Promotion Intervention

EXPERIMENTAL

The SHP Intervention consists of seven core and five optional modules covering topics related to sexual health. It is delivered in both community (outreach) settings and i clinic-based settings.

Behavioral: Sexual Health Promotion Intervention

Interventions

The seven core modules are 1) the Importance of Sexual Health, 2) Sexual Diversity, 3) HIV and other STIs, 4) Behavioral Risk and Risk Reduction, 5) Alcohol and Drugs, 6) Stigma and 7) Health Seeking Practices. The five optional modules are 1) HIV Treatment and Adherence, 2) Stress Reduction, 3) HIV Status Disclosure, 4) MSM/Gay Disclosure, and 5) Other Sexual Health Concerns

Sexual Health Promotion Intervention

Eligibility Criteria

Age16 Years - 29 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Born biologically male; age 16-29; exchanged sex for money or other material goods with another man in the past 90 days

You may not qualify if:

  • inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hanoi Medical University

Hanoi, Hanoi, Vietnam

Location

Center for Applied Research on Men and Health (CARMAH)

Ho Chi Minh City, Ho Chi Minh CIty, Vietnam

Location

MeSH Terms

Conditions

Chlamydia InfectionsGonorrheaSyphilisHepatitis C

Condition Hierarchy (Ancestors)

Chlamydiaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital DiseasesNeisseriaceae InfectionsTreponemal InfectionsSpirochaetales InfectionsBlood-Borne InfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2014

First Posted

April 24, 2014

Study Start

May 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 28, 2016

Record last verified: 2015-10

Locations